Subcutaneous Semaglutide in Systemic Scleroderma

Launched by SECOND XIANGYA HOSPITAL OF CENTRAL SOUTH UNIVERSITY · Nov 20, 2023

Keywords

ClinConnect Summary

**Summary of the Clinical Trial: Subcutaneous Semaglutide in Systemic Scleroderma**

This clinical trial is investigating a medication called subcutaneous semaglutide to see if it is safe and effective for treating systemic scleroderma, a condition that leads to hardening and thickening of the skin and connective tissues. The trial is currently recruiting participants who are between 18 and 65 years old, including those who have not had good results from other treatments. To be eligible, participants should have a confirmed diagnosis of systemic scleroderma and a specific skin scoring result indicating moderate to severe skin involvement.

Participants in this trial can expect a thorough examination to ensure they meet the inclusion criteria, and they will receive subcutaneous injections of semaglutide. Throughout the study, participants will be closely monitored to assess their health and any changes in their condition. It's important to note that individuals with certain medical histories or conditions, such as severe gastrointestinal issues or active infections, may not be eligible. This trial aims to explore new treatment options for those struggling with systemic scleroderma, offering hope for improved management of this challenging condition.

Gender

ALL

Eligibility criteria

• • Inclusion Criteria:(Those who have not achieved good results after hormone or immunosuppressive therapy)
• • 1. Gender unlimited;
• • 2. Age 18-65 years old (including 65 years old);
• • 3. Patients diagnosed with SSc who meet the 2013 European Union Against Rheumatology (EULAR)/American Society of Rheumatology (ACR) SSc diagnostic classification criteria and exclude infections, tumors, and other connective tissue diseases.
• 4. Has received one or more of the following standard systemic treatments allowed by the research protocol:
• • 1. Before the first subcutaneous injection of the study, oral corticosteroids (prednisone not exceeding 15mg/d or equivalent) were administered for ≥ 8 weeks, and stabilizers were administered for ≥ 4 weeks.
• • 2. Before the first subcutaneous injection of the study, patients were treated with Tofacitinib (5-10mg/d) for ≥ 8 weeks and received a stabilizer dose for ≥ 6 weeks.
• • 3. If one or more of the following immune modulators are used, treatment must be given for ≥ 12 weeks before the start of the study, and treatment with a stabilizer dose must be given for ≥ 6 weeks Oral mycophenolate mofetil (MMF) ≤ 1.5 g/day Methotrexate (MTX) oral ≤ 15 mg/week, combined with folic acid Cyclosporine If the subjects use ≥ 2 of the above immunomodulatory drugs in combination, the appropriateness of the subjects' participation in the study must be discussed with the medical supervisor and study chair before enrollment.
• • 5. A modified Rodnan Skin Score (mRSS) of \> 14
• • 6. Those who sign an informed consent form, voluntarily participate in this project, and are able to complete follow-up as required.
• Exclusion Criteria:
• • 1. Prior to the first dose, Body Mass Index (BMI) \< 18.5 kg/m2; weight loss of 10% within one month or 20% within six months.
• • 2. Family or personal history of type 2 multiple endocrine neoplasia or medullary thyroid carcinoma, with family history involving first-degree relatives.
• • 3. History of malignant tumors or a history of malignant tumors within the past 5 years before screening.
• • 4. Presence of other inflammatory diseases that may interfere with efficacy assessment, including but not limited to rheumatoid arthritis (RA), overlap syndrome, psoriasis, dermatomyositis, multiple sclerosis, Crohn's disease, or active Lyme disease.
• • 5. Severe gastrointestinal complications of systemic sclerosis (SSc), such as significant swallowing difficulties, and severe diseases affecting vital organ systems such as the heart, brain, lungs, liver, kidneys, or blood, as deemed unsuitable for participation in the study by the investigator.
• • 6. Known current active or recurrent severe infections, including active tuberculosis.
• • 7. Congenital immunodeficiency or congenital immunosuppression.
• • 8. Substance abuse, alcoholism, or psychiatric disorders, rendering patients uncooperative or unable to adhere to treatment; poor predictability of compliance.
• • 9. Women who are pregnant, breastfeeding, or planning to become pregnant.
• • 10. Patients currently participating in other clinical trials.